Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NHA 2018-09-28

BioHorizons CAD/CAM Bars

Applicant BioHorizons Implant Systems, Inc.

K-Number K180998

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NXC 2018-09-28

Orthocaps Twinaligner

Applicant Ortho Caps GmbH

K-Number K180241

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PHX 2018-09-28

Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay

Applicant Arthrex, Inc.

K-Number K182039

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OWB 2018-09-28

Alphenix, INFX-8000F/B, V8.0

Applicant Canon Medical Systems Corporation

K-Number K182415

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KLE 2018-09-28

Prime&Bond active Universal Adhesive

Applicant Dentsply Sirona

K-Number K181476

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GWN 2018-09-28

RightEye Vision System

Applicant Righteye, LLC

K-Number K181771

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PCH 2018-09-28

BioCode Gastrointestinal Pathogen Panel (GPP)

Applicant Applied BioCode, Inc.

K-Number K180041

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FAD 2018-09-28

Seidmon Antegrade AQ Stent Set

Applicant Cook Incorporated

K-Number K180216

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GAM 2018-09-28

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture

Applicant ETHICON, Inc.

K-Number K181652

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KSB 2018-09-28

Kawasumi Laboratories Blood Drawing Kit (BDK) System

Applicant Kawasumi Laboratories, Inc.

K-Number K172957

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HFG 2018-09-28

Acessa ProVu System

Applicant Acessa Health, Inc.

K-Number K181124

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IYN 2018-09-28

E-CUBE 12

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K181277

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